RecruitingNot ApplicableNCT06496438

Probiotics for Depression in Cancer Patients

Psychobiotics Ameliorate Anxiety and Depression Status in Patients Under Chemotherapy for Gastrointestinal Malignancies


Sponsor

Aristotle University Of Thessaloniki

Enrollment

270 participants

Start Date

Nov 15, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

Anxiety and depressive disorders are quite prevalent in the general population. In 2015, it was estimated that 3.6% of the world population (around 264 million individuals) live with depression and 4.4% (around 322 million) with anxiety, while in the recent years of the COVID-19 pandemic, the prevalence of these disorders has significantly increased. According to the American Psychiatric Association, in 2013 depression was defined as a serious mental illness characterized by decreased mood lasting more than 15 days, a lack of interest, and (even) apathy to normal daily activities. Depression, particularly in its severe form - the major depressive disorder (MDD), is the second leading cause of disability and the most common emotional disorder. Recent research data indicate that this psychiatric disorder, as also similar neuropsychological conditions (Parkinson's, autism, etc.) have, as their main substrate, a disturbance in the diversity of the gut microbiome. More specifically, it has been shown that there is a direct and bidirectional communication between gut and brain - the "gut-brain-axis". The gut, through its microbiome, communicates with the brain by means of neural, immunological, and metabolic pathways, either directly, through the vagus nerve or indirectly, either through the microbiome immunomodulation or the tryptophan pathway, or by the production of various neuroactive molecules. The disturbance in the diversity of the gut microbiome, termed dysbiosis, involves changes in the composition and the number of bacteria genera; and is causatively related to depression via the gut-brain axis. The transmission of nerve impulses, both via the hypothalamic-pituitary-adrenal axis and via the vagus nerve is disrupted by dysbiosis, leading to anxiety and depression, or, conversely, stressful conditions, more particularly emotional stress, which triggers an imbalance in the hypothalamic-pituitary-adrenal axis, leading to systemic immune responses and intestinal dysbiosis. This imbalance can clinically manifest with alterations in digestive tract function, knowledge accepted since the beginning of the previous century. Nowadays, there is considerable evidence that the gut microbiome represents a novel anti-depressant and the term "psychobiotics" has been used to describe those species of probiotic bacteria excreting mental health benefits. Certain Bifidobacterium and Lactobacillus species have already demonstrated, both experimentally and in clinical studies, their capability to improve mood, reduce anxiety, and enhance cognitive function. On these grounds, it is reasonable to raise the hypothesis that, by restoring the diversity of the gut microbiome, and thus enhancing the population of these specific probiotic species - termed 'psychobiotics', due to their specified functions, - could at least lead to an improvement in neuro-psychological disorders through gut-brain-axis remodeling.


Eligibility

Min Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether taking a probiotic supplement can help reduce depression in cancer patients who have had surgery on their digestive tract and are now undergoing chemotherapy. **You may be eligible if...** - You are between 19 and 84 years old - You have been diagnosed with a digestive tract cancer (confirmed by biopsy), had the tumor surgically removed, and are currently receiving chemotherapy - You have provided consent to participate **You may NOT be eligible if...** - You do not understand or speak Greek - You have dementia or a pre-existing psychiatric condition - You are already taking probiotic supplements (other than yogurt) - You are participating in another clinical trial - You have consumed fewer than a certain number of doses of a relevant medication (specific threshold applies) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTPsychobiotics

Dietary Supplement: A four probiotic regime, containing Lactobacillus rhamnosus, Bifidobacterium animalis subsp. lactis, Bifidobacterium breve, and Bifidobacterium longum at a concentration of 1, 000,000,000 CFU.

OTHERPlacebo

The placebo regime, containing powdered glucose polymer, will be identical in packaging, appearance, consistency, and solubility in drinking water, thus making it impossible to recognize which are placebo and which the therapeutic formulation. Both will be identically standardized by the same pharmaceutical company \[Uni-Pharma, Greece\].


Locations(1)

AHEPA University Hospital

Thessaloniki, Greece

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NCT06496438


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